Quality Director, Good Tissue Practices (Contract) 2052

Company: Vertex
Location: Boston
Posted on: January 29, 2025

Job Description:

Job DescriptionThe Director of Quality will focus on Good Tissue Practices and assessment and implementation of regulations. The position must work cross-functionally across the organization and have excellent communication and collaboration skills. The candidate must have experience working with EU regulations for tissue licensing as well as Import/Export Tissue experience.Key Duties & Responsibilities

• Lead the cross-functional team to assess the impact of regulations to the Vertex organization.
• Provide guidance and expertise to the team on regulatory expectations, standard practices in the industry, and options for implementation.
• Work cross-functionally and collaboratively to evaluate the quality systems and processes across the Vertex organization and across GxPs to ensure full impact is evaluated, assessed, and documented.
• Organize, lead, and develop strategy for implementation as well as projected timelines and potential critical path items.
• Report out on the progress of the program, status, and identified issues.
• Identify and escalate risks as required.Required Education Level
  • Bachelor's degree in a scientific discipline, operations research, operations management, or a related fieldRequired Experience
    • Typically requires 5-10 years of relevant experience or the equivalent combination of education and experienceRequired Knowledge/Skills
      • Expert knowledge of global GTP requirements governing CGT products
      • Ability to evaluate quality matters and make decisions utilizing risk-based approach
      • Solid quality culture knowledge and understanding of how to influence without authority
      • Superb facilitation, communication, and coaching/influencing skills with proven ability to lead teams
      • Experience across multiple GxP areas
      • Proven ability to identify and analyze performance indicators.Pay Range$100-$115/hr
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Keywords: Vertex, Newton , Quality Director, Good Tissue Practices (Contract) 2052, Executive , Boston, Massachusetts